Medical Writer, Sr. Associate/Scientist - Medical Writing (MD) at ClinChoice

Yerevan, , Armenia -

Full Time

Start Date

Immediate

Expiry Date

11 Feb, 26

Salary

0.0

Posted On

13 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Regulatory Documents, Literature Review, Data Analysis, Clinical Evaluation, Post-Market Surveillance, Time Management, Collaboration, Mentoring, Quality Assurance, Compliance, Communication, Analytical Skills, Microsoft Office, Research Methodology, Device Technology

Industry

Pharmaceutical Manufacturing

Description

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as an Medical Writer, Sr. Associate/Scientist - Medical Writing (MD) on a permanent basis. Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Position Overview: The Medical Writer (MW) plans and executes assigned medical writing activities including conducting systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), Post-Market Surveillance (PMS) including Periodic Safety Update Reports (PSUR), and Premarket Approval (PMA) Food and Drug Administration (FDA) Reports, including Humanitarian Device Exemption (HDE) and Investigative Device Exemption (IDE) Reports. Main Job Tasks and Responsibilities: Responsible for authoring/reviewing/supporting regulatory documents (which include, but are not limited to, Systematic Literature Reviews as support for Clinical Evaluation Reports, Post-Market Surveillance Reports and Premarket Approval Reports) as per client requirements using the assigned template within an assigned timeline, Prepares, writes and edits literature review reports with the aim of synthesizing and analyzing clinical data from medical and scientific publications, Participates in all phases of the systematic literature review process, from planning to execution, which include (aside from literature protocol and report writing) literature search, literature screening, literature appraisal and data extraction, and data analysis, Ensures template and style guidelines are followed as appropriate, Utilizes available software, such as literature processing tools, to perform specific tasks within the scope of work, Communicates and collaborates with other team members and client stakeholders to ensure project timelines and quality standards of deliverables are met, Demonstrates an understanding in assigned therapeutic areas, provides expertise in device technology, interprets clinical research methodology and study designs, ensures compliance with medical device regulations globally, and escalates any new or emerging risks. Supports review of work done by peer teammates, on need basis, Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues are encountered impacting the delivery schedule, Effectively organize and delegate work where applicable to complete the assigned tasks to meet deadlines, Mentor and bestow domain knowledge to the team, Ensure the assigned tasks are delivered 100% on time or before, as per project SLA, Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work, Be able to independently perform tasks with minimal guidance & supervision, Functionally review the team’s work for accuracy and compliance where applicable, Ensure proper planning of the deliverable and foresee any risks that are likely to arise, Ensure error free and 100% quality in assigned deliverables, Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year, Responsible to ensure training compliance and timesheet compliance, Conduct functional training for the team members, Support in the functional capability development of junior members, Follow and comply with the Company’s Code of Conduct, Policies, and Procedures, Responsible for confidentiality, integrity, availability, and safeguarding of data, Responsible for reporting of security incidents and PIMS breaches as applicable, Comply with company QMS, ISMS and PIMS requirements and applicable regulatory requirements, Demonstrate adherence and compliance to PIMS/GDPR requirements as follows: processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner. Education and Experience: Minimum bachelor’s degree in any life sciences field, 3-5 years of experience in medical writing, or any related field as applicable, Can work in a diverse team environment, Good analytical and comprehension skills, Proficient in time management and can work with minimal supervision, Proficient in oral and written English language, Proficient in Microsoft Office Suites (e.g. Word, Excel, PPT, SharePoint). Our Benefits: Flexible Working Hours Full performance and development process with end of year reviews Team events and end of year party Employee satisfaction survey - your feedback is important for continuous improvement Health Insurance The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare! Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Responsibilities

The Medical Writer is responsible for planning and executing medical writing activities, including conducting systematic literature reviews and authoring regulatory documents. They ensure compliance with medical device regulations and collaborate with team members and stakeholders to meet project timelines and quality standards.